K210199 is an FDA 510(k) clearance for the RICOH MEG. This device is classified as a Source Localization Software For Electroencephalograph Or Magnetoencephalograph (Class II - Special Controls, product code OLX).
Submitted by Ricoh Company, Ltd. (Kanazawa-Shi, JP). The FDA issued a Cleared decision on July 2, 2021, 158 days after receiving the submission on January 25, 2021.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1400. Correlation Of Electrical Activity Of The Brain Using Various Neuroimaging Modalities For Source-localization.
| 510(k) Number | K210199 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 25, 2021 |
| Decision Date | July 02, 2021 |
| Days to Decision | 158 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | OLX - Source Localization Software For Electroencephalograph Or Magnetoencephalograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1400 |
| Definition | Correlation Of Electrical Activity Of The Brain Using Various Neuroimaging Modalities For Source-localization |